e-Cigarettes Versus NRT Gum for Smoking Cessation

NCT ID: NCT01925781

Last Updated: 2016-01-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a randomized trial comparing electronic cigarettes (e-Cigarettes) to nicotine gum for smoking cessation. Participants will be randomly assigned to either e-cigarette use or nicotine gum use during a quit attempt. All participants will have a one hour meeting with a tobacco treatment specialist to develop a quit plan and set a quit date. Quit status will be determined at 12 weeks after the quit date. Continued use of nicotine replacement (either e-Cigarette or nicotine gum) and satisfaction with the treatment assignment will be evaluated.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nicotine Addiction Smoking Cessation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

e-Cigarette

STAM 1100mAh CE4 eGo Clearomizer e-Cigarette

Group Type EXPERIMENTAL

STAM 1100mAh CE4 eGo Clearomizer

Intervention Type OTHER

Nicotine polacrilex

Nicotine Replacement gum

Group Type ACTIVE_COMPARATOR

Nicotine polacrilex

Intervention Type DRUG

2 mg and 4 mg gum will be used according to the FDA approved product labelling

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nicotine polacrilex

2 mg and 4 mg gum will be used according to the FDA approved product labelling

Intervention Type DRUG

STAM 1100mAh CE4 eGo Clearomizer

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Nicotine Gum e-Cigarette electronic nicotine delivery device

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Smokes at least five cigarettes per day
* No current or previous regular use of e-cigarettes
* Ready to quit smoking

Exclusion Criteria

* Use of smokeless or pipe tobacco
* Smoke more than 40 cigarettes per day
* Pregnant or breastfeeding
* Unable to chew gum due to dental or jaw problems
* Myocardial infarction (heart attack) within the previous 12 months
* Hypersensitivity to propylene glycol or nicotine gum
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Creighton University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amy J Arouni, MD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Creighton University

Omaha, Nebraska, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

13-16684

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

QuitAid Pilot Feasibility Trial
NCT05649241 COMPLETED NA
Non-Nicotine Agents for Smoking Cessation
NCT00108537 COMPLETED PHASE3